Diabetic Ketoacidosis and Its Impact on the Brain
Verified June 2014 by Stanford University
William E And Aenid R Weisgerber Foundation
Information provided by (Responsible Party):
Tandy Aye, Stanford University
First received: September 18, 2012
Last updated: June 10, 2014
Last verified: June 2014
About the Study: This research study is being conducted to see if diabetic ketoacidosis has any impact on learning, behavior and development in children with Type 1 diabetes mellitus. If there is an impact, is it transient or persistent? Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a non-sedated MRI scan of the head performed. The investigators will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood glucose values as required by your doctor and bring their meter(s) for downloading to each visit. The children with Type 1 diabetes mellitus should also tell your doctor about the frequency of severe low and high blood glucose values.
||Time Perspective: Prospective
||Diabetic Ketoacidosis and Its Impact on Neurocognition
Primary Outcome Measures:
- Memory score on ImPACT testing [ Time Frame: 15 months ] [ Designated as safety issue: No ]
The computerized electronic testing generates a standardized test score at the complete of the test. The scores will be compared from enrollment, one week, one month and at 3 months. The change in score from enrollment to one week with be the main number used for analysis
Biospecimen Retention: None Retained
Secondary Outcome Measures:
There is no intervention. All subjects with DM and controls get neurocognitive testing and an MRI of the brain. We want to see if the scores are different but no changes in therapy will be done.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2020 (Final data collection date for primary outcome measure)
- One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological testing and to become familiar with the MRI scanner.
- Subjects who need to become more familiar with the MRI scanning process will view a video tape at home.
- One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head completed.
- Subjects between 10 and 17 years of age will also be asked to complete two additional abbreviated neuropsychological tests at one week and one month from enrollment.
- Subjects may have the complete neuropsychological testing and MRI scan repeated 15 months from time of enrollment.
|Ages Eligible for Study:
||4 Years to 16 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a non-sedated MRI scan of the head performed. We will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus.
To take part in the study, the participant must meet the following inclusion criteria:
- Be between the ages of 4 to 17 years.
- Either has been diagnosed with type 1 diabetes mellitus OR does not have type 1 diabetes mellitus
If the interested participant has a history of head trauma with any loss of consciousness, prematurity (born less than 30 weeks of gestation), significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age), neurologic disease independent of diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal appliances such as braces).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753934
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
|Contact: Tandy Aye, MD 650-723-5791 firstname.lastname@example.org |
|Principal Investigator: Tandy Aye MD |
William E And Aenid R Weisgerber Foundation
||Tandy Aye MD
No publications provided
||Tandy Aye, Assistant Professor, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 18, 2012
||June 10, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Endocrine System Diseases
Glucose Metabolism Disorders